ABOUT PREZISTA PREZISTA®
PREZISTA®
® (darunavir) is a prescription medicine. It is one treatment option
in the class of HIV (human immunodefi ciency virus) medicines known as protease inhibitors.
in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA®
with PREZISTA®
/ritonavir (Norvir®
Your healthcare professional will work with you to fi nd the right combination of HIV medicines
professional during treatment with PREZISTA®
PREZISTA® does not cure HIV infection or AIDS and you may
continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.®
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA®
is right for you.
IMPORTANT SAFETY INFORMATION ?
® PREZISTA,® together with Norvir®
What is the most important information I should know about PREZISTA®
can interact with other medicines and cause
serious side effects. See “Who should not take PREZISTA® ® may cause liver problems. Some people taking
(ritonavir), have developed liver
problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.®
If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite
® may cause a severe or life-threatening skin
reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA®
and ritonavir combination treatment
and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or infl amed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA®
and raltegravir together than with either drug separately, but was generally mild
Who should not take PREZISTA® ®
Migranal® ?
medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,®
if you are taking the following ), ergonovine, ergotamine (Cafergot,®
methylergonovine, cisapride (Propulsid® midazolam, triazolam (Halcion®
Simcor,® Vytorin® ), pimozide (Orap®
(Hypericum perforatum), lovastatin (Mevacor,® simvastatin (Zocor,®
), rifampin (Rifadin,®
Ergomar® ), oral
Advicor® Rifater,®
), ),
), the herbal supplement St. John’s wort Altoprev,®
?” ) may increase your ability to fi ght HIV.
is always taken with and at the same time as ritonavir (Norvir® should also be taken with food.
), Rifamate,® Rimactane® or telaprevir (Incivek™ ), sildenafi l (Revatio®
), saquinavir (Invirase® )
pulmonary arterial hypertension, indinavir (Crixivan® ritonavir (Kaletra®
,® are taking sildenafi l (Viagra,® tadalafi l (Cialis,® (Crestor®
Adcirca® Col-Probenecid®
) when used to treat ), lopinavir/
), boceprevir (Victrelis™
tell your healthcare professional if you Revatio®
), atorvastatin (Lipitor® ), pravastatin (Pravachol®
), vardenafi l (Levitra,® ), or colchicine (Colcrys,®
estrogen-based contraceptives (birth control). PREZISTA® ), rosuvastatin
). Tell your healthcare professional if you are taking might
reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms
This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA® ,®
? tell your healthcare professional if you have
any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
to become pregnant, or are breastfeeding
— The effects of PREZISTA®
babies are not known. You and your healthcare professional will need to decide if taking PREZISTA®
on pregnant women or their unborn is right for you
— Do not breastfeed. It is not known if PREZISTA® can be passed
to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk
What are the possible side effects of PREZISTA® ?
increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®
HIV medicines, including PREZISTA.®
effects of these conditions are not known at this time
start taking HIV medicines. Your immune system may get stronger and begin to fi ght infections that have been hidden
® include
diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA®
or any other medicines without fi rst talking to your healthcare professional
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir® ) Product Information (PI and PPI) for additional information on precautionary measures.
Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor.
The cause and long-term health ), Staxyn® ),
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